Author Topic: The "Ask millahh about Pharma" thread!  (Read 1312 times)

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Offline millahh

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The "Ask millahh about Pharma" thread!
« on: June 16, 2017, 01:19:12 PM »
Buried in the early part of the ACA thread, people had put some questions to me about drug development/access/regulatory/pricing/IP/etc., but I wound up taking a bit of a hiatus (to spend more time on drug development, ironically), and so now they're buried/lost.  But this is an area that people of all political stripes have a lot of misconceptions about, so i'm making a dedicated thread for Q&A.  And ask whatever questions you want (don't have to be "hot-button" ones), and if I don't immediately know, I can do a little digging and translate to lay language (which will be educational for me!)

A little background, I work for a mid/large pharma company, doing R&D for innovative drugs.  I work primarily on GI drugs, though have experience with some others.  My training and most of my professional experience is in chemistry, though I have taken on more strategic roles over the last few years, including being the program lead on compound that is about to go into Phase 3 clinical trials.  My experience is largely US, but I have some exposure to ex-US markets and Regulatory.

Go!
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Offline bosk1

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Re: The "Ask millahh about Pharma" thread!
« Reply #1 on: June 16, 2017, 01:34:09 PM »
Why is pharma evil and the tool of Satan?
"The Supreme Court of the United States has descended from the disciplined legal reasoning of John Marshall and Joseph Story to the mystical aphorisms of the fortune cookie."

Offline Adami

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Re: The "Ask millahh about Pharma" thread!
« Reply #2 on: June 16, 2017, 01:45:10 PM »
Why does pharma like watching people suffer? Is there a secret plan to power some secret object by siphoning the suffering of others? 
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Online El Barto

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Re: The "Ask millahh about Pharma" thread!
« Reply #3 on: June 16, 2017, 01:52:14 PM »
Can you feel the difference between having an intact, non-blackened soul, or is it like eyesight where the change is so gradual it goes unnoticed?
Argument, the presentation of reasonable views, never makes headway against conviction, and conviction takes no part in argument because it knows.
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #4 on: June 16, 2017, 01:53:23 PM »
Why is pharma evil and the tool of Satan?
Why does pharma like watching people suffer? Is there a secret plan to power some secret object by siphoning the suffering of others? 

I feel like these two answer each other quite nicely!
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #5 on: June 16, 2017, 01:55:58 PM »
Can you feel the difference between having an intact, non-blackened soul, or is it like eyesight where the change is so gradual it goes unnoticed?

Quote
Audience member: I was just curious - what's in your head, you know, since there's no brain? I mean, is it empty, or is it filled with, say, human excrement?
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Online El Barto

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Re: The "Ask millahh about Pharma" thread!
« Reply #6 on: June 16, 2017, 02:27:01 PM »
Can you feel the difference between having an intact, non-blackened soul, or is it like eyesight where the change is so gradual it goes unnoticed?

Quote
Audience member: I was just curious - what's in your head, you know, since there's no brain? I mean, is it empty, or is it filled with, say, human excrement?
I actually had to look that one up. I knew it was from SNL and I had a vague memory of it, but the details eluded me. Thankfully my research also led me to this:

Quote
I understand, Ref, that you were hit by a bottle after the game?

It was actually a jar.. I believe, sort of a pickle jar. Well, inside the jar was a fetus. It was a pig fetus, not a human fetus like the one in Philadelphia.. and fortunately it didn't shatter, like in Philadelphia.


In all seriousness, you work in a whipping boy industry. From your perspective from various levels within, how much of the dislike is warranted and how much of it isn't?
Argument, the presentation of reasonable views, never makes headway against conviction, and conviction takes no part in argument because it knows.
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Offline Nekov

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Re: The "Ask millahh about Pharma" thread!
« Reply #7 on: June 16, 2017, 02:59:26 PM »
Why are drug prices in the US so damn high? It's ludicrous what you guys charge up there.
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Re: The "Ask millahh about Pharma" thread!
« Reply #8 on: June 16, 2017, 03:36:17 PM »
When are you going to fix IBS?

Offline Stadler

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Re: The "Ask millahh about Pharma" thread!
« Reply #9 on: June 16, 2017, 04:08:31 PM »
What are your thoughts on having the government subsidize and/or outright fund R&D, thus separating that cost component from your profit model?   

Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #10 on: June 16, 2017, 08:36:26 PM »
When are you going to fix IBS?

I already sort of fixed it!

Interesting thing about IBS... It's a "diagnosis of exclusion", meaning it's what the doc is left with after screening for things that are commonly physiologically wrong than can produce similar symptoms (e.g. an obstruction or majorly f'ed up flora).  At that point, it's a collection of symptoms without an obvious underlying cause.  The latest guidance on GI disorders (Rome IV) now categorizes IBS as a brain-gut dysfunction, and actually recommends that therapy and anti-depressants be part of the treatment.  Depression, anxiety, PTSD, history of child abuse etc. can all screw with proper digestive function, and it's now becoming part of the treatment guidelines to address that aspect now that the correlation is better understood.

Good questions so far, but all with much longer answers, so I'll address them tomorrow.
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #11 on: June 17, 2017, 08:10:43 AM »

In all seriousness, you work in a whipping boy industry. From your perspective from various levels within, how much of the dislike is warranted and how much of it isn't?

This is a bit complicated, because it's a very complex industry, but it's something of a case by-case basis.

Cases where it is certainly warranted are ones like Turing, Marathon, Mylan (in the EpiPen instance). These companies did no innovation of their own (or even development on generic competitors), bought exclusive rights to old but essential drugs [EDIT: I clarifyied and mildly corrected on this in my response to Cool Chris] , and then jacked up the prices to absurd extremes.  The executives at those companies deserve all the hate they get, and more.  They are exploiting a rule that was designed to make sure that certain drugs remained available despite them being very old (and therefore unprofitable to make if there was lots of competition)...it's a well-intentioned rule, but with a gaping loophole that can be utilized by people without souls.  The rest of the industry hates these guys (our CEO has excoriated them on TV, and they’ve been kicked out of industry trade groups).  I will add the caveat that not everyone at those companies is evil; non-executives just need jobs like everyone else, and can be just as blindsided and disgusted by these tactics (the guy I knew at Turing proactively left for a different company shortly after that whole debacle broke).

At the other end, you have the small biotechs & startups, where you’ve got a few people with some cash, an idea they believe in, and maybe some VC backing (white coat heroes, if you will).  They typically are hoping to get their drug to a point where it shows a reasonable likelihood of succeeding, then getting bought out by one of the large companies who has deep pockets, experience and manpower to get it through later stage clinical studies and approved.  There’s pretty much nothing for a lay person to dislike here…these businesses are incubators for “miracle drugs” and new technologies that will be too risky for larger companies (for every 10,000 molecules that light up in a test tube, only one will make it to market).  It’s high-risk, high-reward work.  They do not deal with sales/marketing/pricing/etc.

In the middle, you’ve got branded and generic pharma companies.  I work at in branded pharma, which for our purposes may as well mean innovator drugs (either new drugs, or creative repurposing of existing ones).  They either develop their own molecules from the very beginning, or buy something from one of the aforementioned small biotechs that they feel has been adequately de-risked.  They then put it through all of the needed clinical and non-clinical studies, figure out how to manufacture it in a cost effective manner, get through all of the regulatory hurdles, and start selling it.  The “selling it” part is where some of the dislike can start to come in…for innovators, we have a limited patent window where we have the exclusive rights to market the drug, during which not only do development costs need to be recouped, but profit needs to be made*. 

•   On the R&D side, I like to think we’re pretty good people, not deserving of dislike…once you get past the people who are just clocking in and clocking out at lower levels, we’re all motivated by some combination of scientific curiousity, desire to help people, and inherent drive to succeed. 
•   I think Marketing is still fairly clean…they are really looking for win-win scenarios for the patients & company.  The patient can’t benefit from a drug that they (or their doctors) don’t know why it may be appropriate for them, and the company can’t make money if they’re not selling drug. 
•   Sales is where it gets icky.  This is where you get people pushing the envelope ethically, and sometimes outright crossing the lines (and occasionally, someone gets tossed in jail for orchestrating kickback schemes).  It also seems to be a pretty petty and backstabbing environment (seeing them post on industry message boards), and they mostly seem to be pretty faces who can recite a script rather than people who really care about making a difference.  Lots of ex-cheerleaders.  I’ll admit my own dislike for this side of the business.

*(It costs $1-2 billion beginning-to-end to develop a drug, and only 1/10,000 make it all the way, so you can see how development costs start to add up in a hurry)

Then there are generic companies, who develop copies of innovator drugs, to be sold once patent exclusivity is up.  Very different business model, selling lots of different drugs at high volume and low cost, with a very thin profit margin.  They only have just enough clinical to demonstrate that their version behaves the same as the innovator.  They employ mostly manufacturing and lawyers, since it is a constant battle with the innovator companies over validity and enforceability of IP, and they are always trying to design their products around the existing protections.  There is a lot to dislike here if you work for an innovator company (since their tactics are not always intellectually honest, but that cuts both ways), but not much to dislike from a patient perspective. The folks I know who are in these companies by choice are competitive and enjoy complex challenges.   However, some of these companies do have branded drugs that they acquired, and the same Sales issues arise in those cases (plus, Mylan is a generic company, and they’re behind the Epi-Pen debacle).

I don't know if I really answered your question?  Though this does get at one of the common misconceptions that is out there...there is no such thing as monolithic "Big Pharma", and so there's not really a one-size-fits-all answer for anything.
« Last Edit: June 18, 2017, 09:46:33 AM by millahh »
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #12 on: June 17, 2017, 08:47:03 AM »
[Placeholder for a caveat on Marketing being "clean", specifically as it relates to the opiod epidemic & Ohio lawsuit]
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Re: The "Ask millahh about Pharma" thread!
« Reply #13 on: June 17, 2017, 09:17:10 AM »
How often do you think it happens that pharma companies know of major side effects but sweep it under the rug and try to justify away the risks? Does this kind of thing happen at upper levels or is it more on the R&D/clinical side where the guys developing the drugs really want it to work?

My hope in humanity tells me that this is rare, but I fear it's more common that I'd like to think.

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Re: The "Ask millahh about Pharma" thread!
« Reply #14 on: June 17, 2017, 11:05:53 AM »
Your earlier answer was what I was looking for. Examples pro-con.

Lordxizor leads into my next question. What went wrong with Vioxx? We often hear about the pain in the ass that regulation/qualification is. I like to think that it's there for a reason, but then you run into cases like that. From where you sit how close are we to the proper fulcrum point balancing proper vetting with efficiency in both time and expense?
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Re: The "Ask millahh about Pharma" thread!
« Reply #15 on: June 17, 2017, 10:17:30 PM »
That was quite a fascinating read, thanks for taking the time.


Quick question about a drug I'm taking for my psoriasis, Otezla. Now, I have excellent insurance, and no matter the drug, my copay is $5 for generic and $20 for a brand name. Otezla runs, according to a quick google search, around $2600 for 60 pills. Does my provider (Kaiser Permanente) absorb that cost, or how does that work for a new drug that is so prohibitively costly? How does it get a big enough customer base to get rolling as a viable product?
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Offline Cool Chris

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Re: The "Ask millahh about Pharma" thread!
« Reply #16 on: June 18, 2017, 12:29:20 AM »
They are exploiting a rule that was designed to make sure that certain drugs remained available despite them being very old (and therefore unprofitable to make if there was lots of competition)...it's a well-intentioned rule, but with a gaping loophole that can be utilized by people without souls.

Could you elaborate on this?
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #17 on: June 18, 2017, 07:22:40 AM »
They are exploiting a rule that was designed to make sure that certain drugs remained available despite them being very old (and therefore unprofitable to make if there was lots of competition)...it's a well-intentioned rule, but with a gaping loophole that can be utilized by people without souls.

Could you elaborate on this?

Excellent, a (relatively) easy one!

The FDA has an unapproved-drugs initiative, for drugs that went into use before modern standards for safety, efficacy and quality were implemented.  Obviously, FDA has an interest in all drugs that people are taking be up to modern standards.  So, they created a program that is somewhat analogous to the development/approval process for a new drug:  Do some clinical (and probably some non-clinical [e.g. animal]) work to verify and quantify the efficacy and safety, and tighten the quality requirements, and you get an approval with a 3-7 year window of exclusivity to market it.  At that point, the old versions can no longer be sold (as there is a version of the drug available that meets modern standards), and generic competitors cannot put something on the market until the exclusivity period is up.  The exclusivity is important, as the modernization work would be a money-losing proposition if generics could come in quickly.  The exclusivity provides an incentive for the companies willing to do the work.  Good idea, right?

Well, sort of.  It works well when dealing with reasonable, ethical people who care about patients and who are concerned with their own reputation and that of the industry as a whole (which does describe most of us!).  However, it is ripe for exploitation by people like Shkreli, et al.  Pick a drug that you know will be easy to modernize, and do the work.  Get approval and become the sole supplier, then raise prices 5,000%.  And as a bonus, if the drug is used in an orphan indication (affects less than 4,000 people), you can get a longer exclusivity window…and since some of these drugs are used in both broad indications and orphan ones, you can file only in the orphan indication, know that both the orphan and broad populations will still need it (the broad population will just take it off-label).  So it becomes a license to extort patients, Medicaid, insurance companies, the VA, etc.  And since FDA has no authority over pricing, it is quite difficult to stop the people doing this.
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #18 on: June 18, 2017, 09:44:37 AM »
How often do you think it happens that pharma companies know of major side effects but sweep it under the rug and try to justify away the risks? Does this kind of thing happen at upper levels or is it more on the R&D/clinical side where the guys developing the drugs really want it to work?

My hope in humanity tells me that this is rare, but I fear it's more common that I'd like to think.

As with everything else here, it’s complicated. I honestly think there is very little that would be considered “sweeping it under the rug”…but justifying risks is a central component of the process, and I’ll get to that shortly.

Most drugs with significant safety issues get screened out in earlier-phase clinical studies, because there is an aversion to wasting additional money studying a dog.  So the type of scenario you are thinking of could only occur with something that is about to be filed, or is already marketed. 
Most reasonably expected safety issues are addressed as part of the Phase 3 safety/efficacy study design, and this is all agreed to with FDA (or whatever your local regulatory agency is) up front.  You do your own analysis of the data, but you also have to turn your “raw” data over to FDA for them to do their own analyses of it.  So, very tough to hide adverse events seen during development.  Also, ethics and legality aside, better to have the risks identified up front and have the drug properly labeled than have it bite you in the ass a few years later.  Total Vioxx sales would have been higher had it been labeled appropriately from the start, rather than it being a blockbuster, then scandal, being pulled from the market, then being re-introduced with the proper warnings plus a whole lot of stigma).

For post-marketing, there are all sorts of rules around reporting of adverse events (in fact, I had to submit a report to our safety system based on a comment a DTFer made about a bad experience with one of our drugs).  This data routinely has to be submitted to FDA, and there are rules requiring ad hoc reports for severe adverse events, and all of this undergoes analysis to identify rare/unexpected safety issues.  So, nowhere to conceal anything here.

Now where it gets more complicated.  All information (about anything, really) is dealt with on a continuum, neutral reporting to interpretation/spin to misrepresentation to fraud (fabrication or omission).  The relationship between drug companies and regulators is necessarily somewhat adversarial, with each side taking opposite positions in the interpretation/spin part of the continuum.  This tension ideally creates a situation where drugs are labeled for their benefits to patients (but not labeled beyond the proven benefits), and the safety risks are well-described and can be taken into account be prescribers.  Some of what goes on here with safety data is thrashing through whether or not something is a meaningful observation (does it indicate a real risk?  Was it random? Would a patient this sick have had the same thing happen anyway?, etc.), does the benefit outweigh the risk, and how it should be captured in the label.  It can be messy and protracted.  And because it’s all new information on a new drug, it’s not really known what the “right” answer is (as the saying goes, if we knew what we were doing, it wouldn’t be research).  It’s in this area where things can slip through, even if everyone is trying to do the right thing.  You have two sides working with the same information, but advocating from different perspectives.  It’s difficult to say where the line is between explanation and rationalization, what is an appropriate justification and what is not so appropriate.  One outcome is that you get a certain safety language on your label at approval, which can be loosened if you do more studies after approval to show that a certain risk isn’t real, or is less than it first appeared to be.

The “Company X knew the risks!!1!” stuff tends to be in the area of what I just described…there may be an interpretation that shows that risk, but other reasonable (and perhaps more likely) ones that don’t.  And outside of outright malfeasance, the company and the regulators are looking at the same data.  Outright fraud and hiding data is rare, criminal, and will always be found out eventually.

In the instance of Vioxx, there were some cardiac issues observed, but they were rationalized away or inappropriately excluded:
•   There were some severe adverse events that occurred in study subjects shortly after the study had concluded; these should have been given significant attention, but because they were outside the protocol, they were “conveniently” ignored, despite smoke indicating a likely fire (it’s a little more complicated than this, different things were told to different people)
•   There was an a 2x greater risk of heart attack shown for Vioxx relative to the comparator drug (naproxen), but it was rationalized that Naproxen was having a “protective effect”, and that the Vioxx rate was the true baseline level, and that seems to be bullshit.  However…the risk is no greater than with chronic use of ibuprofen.  So had it just been labeled correctly from the start, it might not have been such a big problem.
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #19 on: June 18, 2017, 10:50:57 AM »
What are your thoughts on having the government subsidize and/or outright fund R&D, thus separating that cost component from your profit model?

Ok, this is an interesting one, but tough to answer because it could be interpreted to mean a number of different things.  So, I’ll lay out some of the considerations that would go into answering it:

•   As mentioned upthread, drug development is fucking expensive.  $1+ billion and ~10 years per approved drug, and if you take attrition rates into account, it takes about $2.6 bn in R&D to get an approved drug.  The costs get greater as it gets further into development, as the studies get larger and more complex
•   Many times, studies are conducted in multiple countries, either to get enough patients for the study to meaningful, or to actually support filing in those countries (some countries/regions require that you have local subjects included in your studies to get approval there); this raises the issue of the government effectively subsidizing development of drugs that are to be marketed in other countries
•   How would need for a drug be assessed?  In the case of something like an anti-infective, it might actually be somewhat straightforward.  But what about something like an SSRI, where there are already a bunch on the market, but no two of them perform the same for a given person (and the same ones perform differently between people), and they are iteratively improving?  Would the unmet need be perceived as sufficient to warrant sinking additional billions of dollars in?  Would it be perceived as being “good enough”?
•   How would a threshold for what warrants funding be established (e.g. how many sufferers must there be)?
•   The government’s risk tolerance would likely be much lower than that of private industry, which would likely mean less investment in high-risk, high-reward therapies
•   Whenever a new drug goes on the market, lawsuits invariably follow, and the gov’t might now be a party to the development…what wrenches does that throw in?
•   How are boom/bust cycles in funding handled?  Developing a drug is necessarily playing the long game, and a funding cut (for economic or political reasons) could doom a program
•   A lot of lawmakers don’t understand fuck-all about science, and some of them are proud of it.  What impact may that have on what diseases are prioritized?  And does drug development risk turning into a pork-barrel thing?  Would “pharmaceutical company lobbyist” suddenly become the most secure, well-paid job in the country?
•   In my response to lordxisor, I described the adversarial relationship between industry and the FDA…government funding of R&D would seem to create a conflict of interest for FDA at that point, and making it subject to significant political pressure
•   I’m sure there are many more considerations, but those are just the first few that pop to mind

I should note that there are already incentives from the government for certain activities:
•   If you complete studies for your drug in pediatric populations, you get an extra six months of exclusivity
•   If you are developing a drug for an orphan indication, you can get by with a much smaller set of data and a shorter development time
•   There are some accelerated development/approval pathways available when you are bringing forward a drug where there is a significant unmet medical need (which means more time on the market under exclusivity…the patent clock starts ticking during development, not when you’re approved, so every day earlier on the market is an extra day of exclusive marketing)

Now, much of what I listed out in the first set of bullets could be mitigated if the grants were only covering early research, but then the companies would still bear absorbing the cost and risk of full development, so I don’t know how many companies would accept the seed money if it brought significant restrictions down the line (I highly doubt shareholders would be pleased).  I tend to think that the most effective way that gov’t could seed research is with grants to universities doing basic research, which then gets published, and drug companies then figure out what they can do with that knowledge.  But that doesn’t impact pricing, which was integral to your question.

I’ve been known to give Capitalism some side-eye, and don’t think that the invisible hand always leads us to the optimal outcome, but in this case I’m struggling to see how much good would come from getting government more involved.
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Offline Sir GuitarCozmo

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Re: The "Ask millahh about Pharma" thread!
« Reply #20 on: June 19, 2017, 08:42:59 AM »
Quick question about a drug I'm taking for my psoriasis, Otezla.

My wife uses this and holy shit is it amazing.

Offline Stadler

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Re: The "Ask millahh about Pharma" thread!
« Reply #21 on: June 19, 2017, 10:08:26 AM »
What are your thoughts on having the government subsidize and/or outright fund R&D, thus separating that cost component from your profit model?

Ok, this is an interesting one, but tough to answer because it could be interpreted to mean a number of different things.  So, I’ll lay out some of the considerations that would go into answering it:

•   As mentioned upthread, drug development is fucking expensive.  $1+ billion and ~10 years per approved drug, and if you take attrition rates into account, it takes about $2.6 bn in R&D to get an approved drug.  The costs get greater as it gets further into development, as the studies get larger and more complex
•   Many times, studies are conducted in multiple countries, either to get enough patients for the study to meaningful, or to actually support filing in those countries (some countries/regions require that you have local subjects included in your studies to get approval there); this raises the issue of the government effectively subsidizing development of drugs that are to be marketed in other countries
•   How would need for a drug be assessed?  In the case of something like an anti-infective, it might actually be somewhat straightforward.  But what about something like an SSRI, where there are already a bunch on the market, but no two of them perform the same for a given person (and the same ones perform differently between people), and they are iteratively improving?  Would the unmet need be perceived as sufficient to warrant sinking additional billions of dollars in?  Would it be perceived as being “good enough”?
•   How would a threshold for what warrants funding be established (e.g. how many sufferers must there be)?
•   The government’s risk tolerance would likely be much lower than that of private industry, which would likely mean less investment in high-risk, high-reward therapies
•   Whenever a new drug goes on the market, lawsuits invariably follow, and the gov’t might now be a party to the development…what wrenches does that throw in?
•   How are boom/bust cycles in funding handled?  Developing a drug is necessarily playing the long game, and a funding cut (for economic or political reasons) could doom a program
•   A lot of lawmakers don’t understand fuck-all about science, and some of them are proud of it.  What impact may that have on what diseases are prioritized?  And does drug development risk turning into a pork-barrel thing?  Would “pharmaceutical company lobbyist” suddenly become the most secure, well-paid job in the country?
•   In my response to lordxisor, I described the adversarial relationship between industry and the FDA…government funding of R&D would seem to create a conflict of interest for FDA at that point, and making it subject to significant political pressure
•   I’m sure there are many more considerations, but those are just the first few that pop to mind

I should note that there are already incentives from the government for certain activities:
•   If you complete studies for your drug in pediatric populations, you get an extra six months of exclusivity
•   If you are developing a drug for an orphan indication, you can get by with a much smaller set of data and a shorter development time
•   There are some accelerated development/approval pathways available when you are bringing forward a drug where there is a significant unmet medical need (which means more time on the market under exclusivity…the patent clock starts ticking during development, not when you’re approved, so every day earlier on the market is an extra day of exclusive marketing)

Now, much of what I listed out in the first set of bullets could be mitigated if the grants were only covering early research, but then the companies would still bear absorbing the cost and risk of full development, so I don’t know how many companies would accept the seed money if it brought significant restrictions down the line (I highly doubt shareholders would be pleased).  I tend to think that the most effective way that gov’t could seed research is with grants to universities doing basic research, which then gets published, and drug companies then figure out what they can do with that knowledge.  But that doesn’t impact pricing, which was integral to your question.

I’ve been known to give Capitalism some side-eye, and don’t think that the invisible hand always leads us to the optimal outcome, but in this case I’m struggling to see how much good would come from getting government more involved.

Well, the obvious and most basic is that for a company to invest $2.6 BILLION in something, they have to have some path to get at least $2,600,000,001 in return (and likely a lot more than that).  So how do you incent companies to make that investment proactively, and in cases where there is no possibility of $2,600,001 let alone $2,600,000,001.   In the rail industry, for example, there are grants and subsidies available to pursue R&D in areas that are of interest to the government - and by extension, society - that might or might not ever be a focus of effort via a pure "invisible hand" structure. We're willing to get involved politically (which is not the same as "politicize") pharma, with respect to guaranteeing certain profits, and guaranteeing certain price protections, so why not influence other variables in that equation, like R&D?   

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Re: The "Ask millahh about Pharma" thread!
« Reply #22 on: June 19, 2017, 11:32:10 AM »
I just want to jump in and thank Millahh for starting this thread.  I too work in the pharma industry, and get really tired of all the shit that people throw at us.  The first three replies in this thread show that even when we're trying to do the right thing and actually enlighten people, people will still throw shit.  Information is a good thing and reliable information is a rarity.

So fuck all of you shit-slingers who clearly operate from a position of ignorance, and Thank You to Millahh for being the voice in the storm.

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Re: The "Ask millahh about Pharma" thread!
« Reply #23 on: June 19, 2017, 01:28:54 PM »
I just want to jump in and thank Millahh for starting this thread.  I too work in the pharma industry, and get really tired of all the shit that people throw at us.  The first three replies in this thread show that even when we're trying to do the right thing and actually enlighten people, people will still throw shit.  Information is a good thing and reliable information is a rarity.

So fuck all of you shit-slingers who clearly operate from a position of ignorance, and Thank You to Millahh for being the voice in the storm.

In fairness, it was very good-natured shit slinging :)  And nobody accused me of hiding the cure for cancer!
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Re: The "Ask millahh about Pharma" thread!
« Reply #24 on: June 19, 2017, 04:11:57 PM »
I don't know. I didn't see any smilies or green font. :)

Obviously I'm just too close to the issue. After dealing with the same shit all the time, it's just not funny anymore, not something to even joke about.

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Re: The "Ask millahh about Pharma" thread!
« Reply #25 on: June 19, 2017, 06:19:45 PM »
Quick question about a drug I'm taking for my psoriasis, Otezla.

My wife uses this and holy shit is it amazing.

Yeah, it's pretty dope, I've been trying everything, and other than UV treatment, this has had the best results. Was very thankful not to have to go to an immune suppressor.
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Re: The "Ask millahh about Pharma" thread!
« Reply #26 on: June 21, 2017, 06:17:57 AM »
Haven't forgotten you guys, I have a presentation to the CEO on Monday and that has been drawing my attention a bit!  But, I'm working on a pricing mega-post, and am picking the brains of a couple of colleagues so that I can answer the questions well/comprehensively.
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Re: The "Ask millahh about Pharma" thread!
« Reply #27 on: June 21, 2017, 12:20:06 PM »
Just got back from an offsite meeting involving the combined teams of two VPs, so about 150 of us in a big presentation room, and several dozen in various off-shore locations all in on screens.  It was your typical dog-and-pony show, the latest thing each group is doing, some gee-whiz numbers about product growth and the future, and I always joke that they serve plenty of Kool-aid.  The idea is that we come away feeling all fired up about the work we're doing and what's ahead, and of course happy employees who feel valued tend to perform better than employees who don't feel appreciated and don't give a shit about their work, their jobs, or their company.

Well damn, that must've been some good Kool-aid (and yes, I know that Jones did not serve Kool-aid, but that's the cliché anyway) because I feel pretty good.  I worked on the launch of a product a few years ago and still support that product, and we're into v2.0 of the software and getting ready to launch our second product in the market (technically our third, since the original came in regular and XR).  Since launch, we've cured over 50,000 patients.  It's not just a treatment; it's a cure.  50 thousand people used to have this disease, and now they don't because they took our medicine, and I helped with that.  The new one, which we're hoping to launch later this year, will be even better.  High efficacy in clinical trials, patients cured in 8 weeks, and 95% of all afflicted patients will be able to take this drug.  We make stuff that cures people of horrible diseases.  We are awesome.  I feel good about my job.

And I guess that's why you don't ask Orbert about Pharma.  He'll serve you a big tall glass of some colorful fruit-flavored beverage and dare you to put a price on the work he does.

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Re: The "Ask millahh about Pharma" thread!
« Reply #28 on: June 24, 2017, 01:26:13 PM »
I have a question, maybe a little bit more on the chemical side than was intended here.

Is there any reason for a consumer to not go with a generic equivalent, barring extreme circumstances like allergies to fillers?

There have been many whom have claimed, particularly in regards to Wellbutrin/Bupropion, that things like fillers, release agents, and low inspections/standards affect how well the generic drug works. I myself have been on many generic psychotropics in the past year and a half (escitalopram, dexmethylphenidate XR, bupropion XL, dextroamphetamine XR, mixed amphetamine salt solution with some weird Vyvanse-esque release mechanism, atomoxetine) with varying degrees of uselessness. I wonder if I had splurged at all on brand-name Lexapro/Focalin/Wellbutrin/Dexedrine/Adderall/Vyvanse/Strattera that my results could be different?
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Re: The "Ask millahh about Pharma" thread!
« Reply #29 on: June 24, 2017, 01:49:25 PM »
I have a question, maybe a little bit more on the chemical side than was intended here.

Is there any reason for a consumer to not go with a generic equivalent, barring extreme circumstances like allergies to fillers?

There have been many whom have claimed, particularly in regards to Wellbutrin/Bupropion, that things like fillers, release agents, and low inspections/standards affect how well the generic drug works. I myself have been on many generic psychotropics in the past year and a half (escitalopram, dexmethylphenidate XR, bupropion XL, dextroamphetamine XR, mixed amphetamine salt solution with some weird Vyvanse-esque release mechanism, atomoxetine) with varying degrees of uselessness. I wonder if I had splurged at all on brand-name Lexapro/Focalin/Wellbutrin/Dexedrine/Adderall/Vyvanse/Strattera that my results could be different?

This is right in my wheelhouse!

Most of the time, it's fine, but Wellbutrin was a glaring exception. 

The issue there was a manufacturing subtlety that affects how the drug releases once you take it.   It was developed as an extended-release (XR) formulation, which means that it releases at a roughly constant rate after you ingest it, with the objective being that you get something approximating a steady-state in the body, rather than peaks and troughs corresponding to taking it, getting rapid absorption and distribution, followed quick metabolism, which you typically get with an immediate-release product.  In most of the generic versions, they didn't realize that the moisture level in the tablet was critical...if the level got too high, the drug would actually migrate towards the surface of the tablet, and once it was taken it behaved much more like an immediate-release.  Since Bupropion needs to be at a steady state, people may as well have been taking nothing.  However, those are all off the market or else the processes have been fixed (plus it's on FDA's radar), so at this point, the generics should be fine.

As far as quality standards, I'm not worried about anything that comes from a US or Europe-based company.  Any ingredients sourced from China/India by the US/Europe companies are going to be very thoroughly tested as a means of mitigating risk.  As to finished drugs manufactured by non-western companies, well...

http://fortune.com/2013/05/15/dirty-medicine/
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Re: The "Ask millahh about Pharma" thread!
« Reply #30 on: June 25, 2017, 11:49:59 AM »
So what's the story with branded generics? Seems to create another pricing tier, even though a true generic could already be on the market. My kidney docs weren't keen on generics, but they put me on a BG (Hecoria) rather than generic tacrolimus. Didn't seem to make much sense, since it didn't cost that much less than prograf.
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Re: The "Ask millahh about Pharma" thread!
« Reply #31 on: June 25, 2017, 04:17:08 PM »
I have a question, maybe a little bit more on the chemical side than was intended here.

Is there any reason for a consumer to not go with a generic equivalent, barring extreme circumstances like allergies to fillers?

There have been many whom have claimed, particularly in regards to Wellbutrin/Bupropion, that things like fillers, release agents, and low inspections/standards affect how well the generic drug works. I myself have been on many generic psychotropics in the past year and a half (escitalopram, dexmethylphenidate XR, bupropion XL, dextroamphetamine XR, mixed amphetamine salt solution with some weird Vyvanse-esque release mechanism, atomoxetine) with varying degrees of uselessness. I wonder if I had splurged at all on brand-name Lexapro/Focalin/Wellbutrin/Dexedrine/Adderall/Vyvanse/Strattera that my results could be different?

This is right in my wheelhouse!

Most of the time, it's fine, but Wellbutrin was a glaring exception. 

The issue there was a manufacturing subtlety that affects how the drug releases once you take it.   It was developed as an extended-release (XR) formulation, which means that it releases at a roughly constant rate after you ingest it, with the objective being that you get something approximating a steady-state in the body, rather than peaks and troughs corresponding to taking it, getting rapid absorption and distribution, followed quick metabolism, which you typically get with an immediate-release product.  In most of the generic versions, they didn't realize that the moisture level in the tablet was critical...if the level got too high, the drug would actually migrate towards the surface of the tablet, and once it was taken it behaved much more like an immediate-release.  Since Bupropion needs to be at a steady state, people may as well have been taking nothing.  However, those are all off the market or else the processes have been fixed (plus it's on FDA's radar), so at this point, the generics should be fine.

As far as quality standards, I'm not worried about anything that comes from a US or Europe-based company.  Any ingredients sourced from China/India by the US/Europe companies are going to be very thoroughly tested as a means of mitigating risk.  As to finished drugs manufactured by non-western companies, well...

http://fortune.com/2013/05/15/dirty-medicine/
Thanks for the response. I also wonder about the XR stimulants I was on. People on the internet have possibly found a discrepancy between different manufacturers and their release profiles. The most obvious way to tell them apart is the taste of the external coating: some taste vaguely like vomit, while others taste like plastic (little taste, mostly just mouthfeel). In my experience, the dexmethylphenidate I was on was plasticky, while the dextroamphetamine, which I had obtained from an Express-Scripts mail-order pharmacy that I wouldn't trust as far as I could throw, was vomitty.

Now I'm thinking about begging my doctor for a Vyvanse script. Is there any way that I could get it without paying totally out-of-pocket, other than hitting my deductible? Maybe call the insurance and also get a prior auth or something? Or am I just SOL until next year?
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #32 on: June 25, 2017, 06:03:58 PM »
I have a question, maybe a little bit more on the chemical side than was intended here.

Is there any reason for a consumer to not go with a generic equivalent, barring extreme circumstances like allergies to fillers?

There have been many whom have claimed, particularly in regards to Wellbutrin/Bupropion, that things like fillers, release agents, and low inspections/standards affect how well the generic drug works. I myself have been on many generic psychotropics in the past year and a half (escitalopram, dexmethylphenidate XR, bupropion XL, dextroamphetamine XR, mixed amphetamine salt solution with some weird Vyvanse-esque release mechanism, atomoxetine) with varying degrees of uselessness. I wonder if I had splurged at all on brand-name Lexapro/Focalin/Wellbutrin/Dexedrine/Adderall/Vyvanse/Strattera that my results could be different?

This is right in my wheelhouse!

Most of the time, it's fine, but Wellbutrin was a glaring exception. 

The issue there was a manufacturing subtlety that affects how the drug releases once you take it.   It was developed as an extended-release (XR) formulation, which means that it releases at a roughly constant rate after you ingest it, with the objective being that you get something approximating a steady-state in the body, rather than peaks and troughs corresponding to taking it, getting rapid absorption and distribution, followed quick metabolism, which you typically get with an immediate-release product.  In most of the generic versions, they didn't realize that the moisture level in the tablet was critical...if the level got too high, the drug would actually migrate towards the surface of the tablet, and once it was taken it behaved much more like an immediate-release.  Since Bupropion needs to be at a steady state, people may as well have been taking nothing.  However, those are all off the market or else the processes have been fixed (plus it's on FDA's radar), so at this point, the generics should be fine.

As far as quality standards, I'm not worried about anything that comes from a US or Europe-based company.  Any ingredients sourced from China/India by the US/Europe companies are going to be very thoroughly tested as a means of mitigating risk.  As to finished drugs manufactured by non-western companies, well...

http://fortune.com/2013/05/15/dirty-medicine/
Thanks for the response. I also wonder about the XR stimulants I was on. People on the internet have possibly found a discrepancy between different manufacturers and their release profiles. The most obvious way to tell them apart is the taste of the external coating: some taste vaguely like vomit, while others taste like plastic (little taste, mostly just mouthfeel). In my experience, the dexmethylphenidate I was on was plasticky, while the dextroamphetamine, which I had obtained from an Express-Scripts mail-order pharmacy that I wouldn't trust as far as I could throw, was vomitty.

Now I'm thinking about begging my doctor for a Vyvanse script. Is there any way that I could get it without paying totally out-of-pocket, other than hitting my deductible? Maybe call the insurance and also get a prior auth or something? Or am I just SOL until next year?

Regarding taste and release profiles, one may not correlate to the other.  In order to bring on a generic of any oral drug, the generic manufacturer has to show that their drug is both bioequivalent to the original, and that the in vitro dissolution profile is comparable (Look up USP <711> if interested in the technique).  Sometimes a generic will intentionally have different inactive ingredients (including the type of release-controlling coating used) as a design-around on the innovator's patent.  There are different types of enteric coatings that have different properties, but you can the achieve same performance via multiple approaches.  Conversely, just because they use coatings that seem the same doesn't mean that they are...relative subtleties like polymer molecular weight distribution and manufacturing process can make a huge difference in release behavior.

On the second one...I'm a scientist, I know to not talk about something if I have no f'n clue  :lol
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #33 on: July 02, 2017, 07:41:17 AM »
Just got back from an offsite meeting involving the combined teams of two VPs, so about 150 of us in a big presentation room, and several dozen in various off-shore locations all in on screens.  It was your typical dog-and-pony show, the latest thing each group is doing, some gee-whiz numbers about product growth and the future, and I always joke that they serve plenty of Kool-aid.  The idea is that we come away feeling all fired up about the work we're doing and what's ahead, and of course happy employees who feel valued tend to perform better than employees who don't feel appreciated and don't give a shit about their work, their jobs, or their company.

Well damn, that must've been some good Kool-aid (and yes, I know that Jones did not serve Kool-aid, but that's the cliché anyway) because I feel pretty good.  I worked on the launch of a product a few years ago and still support that product, and we're into v2.0 of the software and getting ready to launch our second product in the market (technically our third, since the original came in regular and XR).  Since launch, we've cured over 50,000 patients.  It's not just a treatment; it's a cure.  50 thousand people used to have this disease, and now they don't because they took our medicine, and I helped with that.  The new one, which we're hoping to launch later this year, will be even better.  High efficacy in clinical trials, patients cured in 8 weeks, and 95% of all afflicted patients will be able to take this drug.  We make stuff that cures people of horrible diseases.  We are awesome.  I feel good about my job.

And I guess that's why you don't ask Orbert about Pharma.  He'll serve you a big tall glass of some colorful fruit-flavored beverage and dare you to put a price on the work he does.
 

You're role is in something IT-related, if I remember correctly?

You used the word "cure", which sets me up nicely for a question i was anticipating but hasn't yet been asked...

No pharma companies are not colluding to hide cures for cancer or other diseases.

•   The industry is cut-throat competitive.  Companies will do whatever they can to be able to say that their drug is even slightly better than the competition (even if it only comes down to perception).  I’ve seen things that would quite accurately be described as “yellow journalism” from competitors.  It’s dog-eat-dog.
•   The idea that there is more money to be made from chronic treatment than curing a disease is false.  I’m still wrapping my head around how US pricing works, but generally speaking, the more money you can save the insurance company (or government payor, as in EU), the more you can charge.  If your drug decreases number of days in the hospital & days of work missed, and increases the patients lifespan (and number of days paying income tax form work and sales tax from spending that money), those are all things that will enable your drug to command a higher price, because the math still works for the payor.  That, combined with the competitive pressure, incentives the hell out of finding cures wherever it’s possible to do so.
•   Creating an industry cabal would be a lot harder than it sounds…there is the heterogeneity of types of companies that I described up-thread, and there are companies from all over the world, each with their own incentives & philosophies.
•   Most pharma companies are publicly held, and shareholders are notoriously short-sighted…they want profit sooner than later, and suppressing a cure goes directly against shareholder interest
•   We’re all human beings, with families and people who are dear to us…diseases affect us all personally.
•   There’s an idea that all diseases are somehow curable in a straightforward manner.  But how easy is it to tell your body to make a hormone that it has somehow been unable to produce since birth?  Is there an obvious switch that can be thrown to prevent your immune system from being over-zealous without at the same time leaving you completely defenseless to everyday threats?  Is it easy to tell a defective gene to do something that is not in its coding?
•   There are cures…Gilead recently launched a cure for hepatitis B/C.  Orbert describes his company releasing cures.  Most anti-infectives are intended to be cures.  And areas like gene therapy and the guy microbiome are really hot areas, which are expected to lead to cures (and the big companies are placing large bets on them leading to cures)

Cures are the holy grail from business, scientific and humanitarian perspectives.  The idea of cure supression sits right alongside chemtrails and NASA running a child slave colony on Mars.
« Last Edit: July 02, 2017, 08:27:48 AM by millahh »
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Re: The "Ask millahh about Pharma" thread!
« Reply #34 on: July 02, 2017, 08:34:43 AM »
I too get pretty tired of all the bullshit conspiracy theories about how we've actually cured most major diseases, but they'll never get to market because we can make more money treating people indefinitely than to outright cure them.  To believe that is to be so paranoid that you have no faith in humanity, or you're just an idiot.  The result is the same and either way, I have no tolerance for such foolishness.  I can believe that one or two guys are that morally bankrupt and might reach positions of power.  The Shkrelis of the world.  I cannot believe that an entire industry, dozens of companies, has somehow secretly gotten together to collude, all outside of the watchful eyes of the FDA.  Just not possible.

But yeah, it's a cure.  Hepatitis C virus is the latest biggie that we're all making progress on.  Take our stuff for 8 to 12 weeks, and if it works, you're cured.  No more HCV.  So with 50,000 down and even more by our competitors, the market has something like a self-reducing effect.  I don't know what it's called, but I'm sure there's a name for it.  After the big hit (which took place over the past few years), now most of "low-hanging fruit" (which is a crude term to use for patients, but that's what they are) has been picked.  The ones which were easiest to cure have been cured.  Gilead got out there first, but we're gaining market share; it's just that the market is shrinking because that's how it works.  You say "recently" but it's been a few years now.

So our next-generation drug is different.  Higher efficacy, shorter term (straight 8 week treatment and you're done), and can be used on nearly 90% of diagnosed patients.  Our first one was only for patients who couldn't take some of the others, or for whom they weren't effective.  The new one covers more indications and is designed to be the one you take first.  Again, there's a term for that but I don't know it.

Yeah, I'm IT; I provide the zillions of gigabytes of data for these guys.  Boring as shit, but I work with some cool people and my work helps cure people, so it's pretty cool.